Health product recall

Silvercel Hydro-Alginate and Tegaderm Alginate, High Integrity Alginate Dressings and ActivHeal Non-Adhesive PHMB Foam

Last updated

Summary

Product
Silvercel Hydro-Alginate and Tegaderm Alginate, High Integrity Alginate Dressings and ActivHeal Non-Adhesive PHMB Foam
Issue
Medical devices - Sterility
What to do

Contact the manufacturer if you require additional information.

Audience
Industry

Affected products

Affected products

Lot or serial number

Model or catalog number

Silvercel Hydro-Alginate Antimicrobial Dressing

W00071172
W00070266
70657V002
71173V002
W00068666
68666V002
W00070657
70266V002

CAD011
CAD7011
CAD050

ActivHeal Non-Adhesive PHMB Foam

W00070461
W00070519

9021348

Tegaderm Alginate, High Integrity Alginate Dressing

W00070779

90112

Issue

On July 25th, AMS staff identified a defect on primary packaging pouches, during packaging, of minor missing patches of polyethylene. The defect could compromise the device's ability to maintain a sterile barrier. In addition, patches of burnt or cracked polyethylene have been identified on the inside face of the primary.

Recall Start Date: October 18, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Health products - Medical devices - General hospital and personal use
Companies

Advanced Medical Solutions Limited

Premier Park, 33 Road One, Winsford, Cheshire, Great Britain, CW7 3RT

Published by
Health Canada
Audience
Industry
Recall class
Type II
Identification number
RA-76598

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